Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martha L. Clabby, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00257517
First received: November 22, 2005
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

This study will assess 75-100 patients for feeding issues following surgery for single ventricle.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • weight gain [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2005
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:

We wish to consent 75-100 subjects at Children's Healthcare of Atlanta.

If subjects take part in this study, the following will happen:

  1. Prior to discharge, the parent/guardian will be given a home feeding log and
  2. Parents will bring the feeding log to regularly scheduled clinic visits. Clinic staff will also weigh the child and measure head circumference at each clinic visit.
  3. The investigators will look at the child's medical record to obtain other information including diagnosis, surgery, oxygen saturation levels and medications.
  4. The parent/guardian will be asked to fill out a questionnaire about their stress and uncertainty caring for their baby after heart surgery. They will be asked to fill out the same questionnaire 3 times:

    • First time will be before they leave the hospital after the baby's surgery, while still a patient on the Cardiac Step Down Unit (CSU).
    • Second time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 4 weeks.
    • Third time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 12 weeks or at the time of the routine cardiac cath prior to their second stage surgery.

It should take about 15 minutes to fill out the questionnaire. The questionnaire is the only research procedure.

The data from the feeding log and clinic visits will be submitted to Cincinnati Children's, the primary site for this study.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hypoplastic left heart syndrome

Criteria

Inclusion Criteria:

  • Single ventricle patients who have received the Norwood Stage I operation.

Exclusion Criteria:

  • Infants with chromosomal anomalies or other non-cardiac conditions (cleft palate, necrotizing enterocolitis [NEC] or other gastrointestinal [GI] anomalies)
  • Prematurity less than 37 weeks
  • Infants greater than 30 days of age at Stage I palliation
  • Parents who cannot read or understand questionnaires administered as a part of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257517

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Martha Clabby, MD Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Martha L. Clabby, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00257517     History of Changes
Other Study ID Numbers: IRB00021873
Study First Received: November 22, 2005
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Congenital heart disease
Single ventricle
Infant feeding

ClinicalTrials.gov processed this record on April 15, 2014